This invention relates to a surgical suture package. The package is self-contained and permits dispensing of a single-armed or double-armed suture, with or without a pledget.
The significance of packaging is most evident in the packaging of surgical sutures. It is essential that the package protect the product and maintain sterility throughout its period of potential use. Sutures may be stored in hospitals for several years, although the usual storage time is much shorter. It is also essential that the package provide rapid and positive means of identification, and release of the undamaged product, ready for use by the surgeon.
There are many sizes of sutures, and many materials of construction such as catgut or polyglycolic acid for absorbables, and silk, cotton, nylon, polyethylene terephthalate, polypropylene, stainless steel, insulated stainless steel and other materials for use as non-absorbables. There are several different needle types in common use including pointed straight, pointed curved, three cornered straight, three cornered curved, curved both regular and reverse cutting, and needles with side cutting edges of various types. The variations and combinations of each of the above, to meet the preferences of many surgeons for different operative procedures, means that the suture manufacturer needs to supply different suture package combinations. These suture package combinations can run into the thousands. The importance of positive identification while maintaining an efficient, economical package can thus be readily appreciated.
It is also important to provide convenience to the surgeon and to limit the risk of accidentally enclosing foreign items in the patient by limiting the number of extraneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifications of accidentally enclosing such material in the patient during the surgical procedure, is it absolutely essential to minimize this hazard.
Finally, it is essential in a package containing a surgical needle or needles, that the suture is protected from contact with the sharp point or cutting edge of the needle, which could partially cut the suture or the package. Also, the armed needle edges and point need to be protected to maintain their sharpness.
The prior art generally discloses a surgical suture or sutures package in a outer envelope. Contained in the outer envelope is an inner envelope or pouch which is sterile. The suture strand or strands have been formed into various configurations of coils and loops, and are contained in or on various retainers, cards, or reels within the inner envelope.
The suture is normally prepared for the surgeon by peeling open the outer envelope and transferring the inner envelope by sterile forceps, or by projecting it across a sterile barrier, into the sterile area of the operating room. The sterile inner envelope is then opened at the time of use.
The package of the present invention has advantages over the prior art. After peeling open the outer envelope, the card containing the suture is exposed. The suture can then be dispensed without opening the card, either from the front (for right-handed arming), or the back (for left-handed arming). The needle is completely visible, as is its point orientation.
Another advantage is that the self-contained suture card can be printed with complete suture and needle identification. Special ink effects, e.g. striping and coloring used in the printing, allows a color coding description of the suture and/or needle materials for ease of identification.
The surgical suture card described is enclosed in an envelope. At least one web of the envelope is a clear (transparent) material which allows full visibility of the descriptive literature on the card. The envelope is sealed by methods known in the art, e.g. heat sealing.
An improved surgical suture package containing a single surgical suture strand (single- or double-armed, with or without a pledget) has been invented. The package comprises a paper or similar material card with four main rectangular panels, such that when folded in a prescribed manner, a suture compartment is created into which the suture may be manually or automatically wound.
The label is divided with perforations or scores into four main panels. Two of these panels 1, 2 are joined at one of the narrower ends. To one of these is connected a third panel 3 along the longer edge. To the other panel is connected a fourth panel 4 along the opposite longer edge. Along the joining edge of these two panels is an opening, either symmetric or asymmetric to the joining edge.
In addition to the main panels, there are three lesser flaps, each connected to a different panel. A flap with slits 5, designed for retaining the various surgical needles, is connected to the third panel on the available longer side. To the shorter edge of the second panel is attached a lesser flap 6 which completes the suture compartment when folded. To the longer edge of the fourth panel is connected a tab 7 which may be tucked into a slit in the second panel upon completion of folding.
Upon complete folding, the aforementioned opening creates a recess, through which the needled suture may be directly accessed without opening any flaps or tabs.
Further, an improvement may be made in which a foam block may be adhered with adhesive on the flap with slits 5 for embedding the needle for tip protection.